Pancreatic cancer elderly unresectable pancreatic cancer patient
Conditions
Interventions
Administration of biweekly Gemcitabine plus Nab-paclitaxel for elderly patients (over 75) with unresectable pancreatic cancer.
Sponsors
Ikezawa Kenji
Takada Ryoji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically-proven adenocarcinoma accompanied by diagnostic imaging consistent with pancreatic cancer 2) Diagnosed as UR-LA or UR-M by chest/abdominal/pelvic CT 3) Without uncontrollable pleural effusion or ascites 4) Age: 75 or more than 75 years old 5) ECOG Performance status (PS) of 0 or 1 6) Estimated life expectancy; more than three months 7) No prior chemotherapy or surgical treatment for pancreatic cancer (except for single laparotomy or digestive tract bypass surgery) 8) No prior treatment for other organ cancer within 6 months 9) Adequate function of major organs 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who prefer standard schedule GnP therapy if applicable 2) Patients who prefer chemoradiation therapy if applicable 3) Severe comorbidities [such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes(HbA1c>=10%)] 4) History of unstable angina pectoris or myocardial infarction within 6 months before registration. 5) Synchronous or metachronous malignancies except for early cancer 6) Infectious diseases (such as HIV, active tuberculosis, or bacterial infection) requiring systemic treatment, except for viral hepatitis and old pulmonary tuberculosis 7) Severe psychological disorder 8) Continuous systemic medication of corticosteroid or immunosuppressant 9) Pulmonary fibrosis or interstitial pneumonia 10) The history of adverse reactions to both of iodinated contrast media and gadolinium contrast media 11) Patients who are judged to be ineligible by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate, incidence of severe adverse events, overall survival (proportion of 1-year survival and 2-year survival), progression free survival, dose intensity, disease control rate | — |
Contacts
Public ContactKenji Ikezawa
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Outcome results
None listed